The Stichting MLC Foundation leads the Ethics and Regulations Work Package (WP2), providing HEAP with expertise in ethics and law, in particular regarding compliance with European GDPR data regulations, and national and institutional regulations.

Ethical, legally compliant handling of patient data

The Ethics and Regulations Work Package (WP2) will develop the HEAP ethical and governance framework to ensure that data are handled legally and in line with the expectations of patients and the public. This will allow data to be shared under controlled and ethical conditions and in compliance with all regulations, including GDPR. Stichting MLC Foundation will work with other European institutions to share best practices and lessons learned about the legal and ethical challenges associated with big data projects. The aim is to contribute to a pan-European consensus on big data processing for better health care.

What are the legal and ethical challenges facing cohorts?

Cohorts with volunteer participants are based on consent. Usually, this is broad consent, meaning consent to the general aims of the cohort. However, the European Data Protection Board (EDPB), in its guidelines on consent, recommends that consent should be for a specific study protocol. This would seem to exclude using cohort data for where the aims are broadly defined such as into factors which contribute to the onset of a very generically described disease, such as cancer, and for improved treatment once it has occurred. 

There are several possible ways to bridge the gap between broad and specific consent. One of them  is to implement granular consent. It is unclear how often this has been attempted in cohorts and if so, what the outcome was, and what proportion of participants dropped out because they either did not agree to the study, or had lost interest in researching the specifics of each new study or in looking at the notification of a new (sub) study.

Another solution could be for the research community to propose an alternative to specific consent for the EDPB’s consideration, such as ‘consent to governance’. Participants then agree to the way how decisions about new studies are made and communicated to them. Yet, there are no guidelines based on practical experiences, as to how such an alternative governance model could be implemented.

Click on the icon to participate in the Participant-facing governance of cohorts questionnaire

The questionnaire is for managers and administrators of data cohorts

About the “Participant-facing governance of cohorts” - questionnaire

In the context of this questionnaire a cohort is an observational research project for which a group of individuals, after having been invited to participate, have submitted data and tissue for the aims of the project. Those aims can be described very broadly (with the UK biobank as a prime example) or more narrowly.

During its lifespan the aims of the project lead to several (sub) studies. The volunteers can be healthy volunteers (at the start of the project) or patients. Cohort data and human samples can come from questionnaires, health screening programmes, health records or data from statistical agencies. The samples can be residual tissue after diagnostic procedures or specifically taken for the project.

(Clarification: Biobanks that store and manage residual tissue with the sole aim that these can be used for a wide variety of research projects, are not considered to be “cohorts” in the sense of this survey).  

Participant-facing governance of cohorts research project

The HEAP Ethics and Regulations workpackage team, led by MLCF, has developed an on-line questionnaire to find out how cohorts are addressing consent and participant facing governance in practice, against the background of the  GDPR and national regulations, and how interactions are being managed between participants and research groups. 

All cohort owners are encouraged to participate, including those participating in European Human Exposome Network (EHEN) projects and cohorts linked to EHEN partner institutions. The research project and questionnaire focuses on two main areas:

  • Participant facing governance, and how to ensure that any follow-on studies using cohort data or tissue follow data protection, ethics, and FAIR data principles.
  • How cohorts strike a balance between efficiently conducting biomedical research using cohort data and samples, while safeguarding the interests of participants and wider society

There is considerable debate about these topics, but little empirical material on how cohorts currently approach them in practice. The research project aims to provide that empirical material. The results from the questionnaire will guide our thinking, and reflect our recommendations on good research governance as a possible alternative to granular consent. Our ELSI research will result in two papers, one presenting the results of the questionnaire, and the second providing reflections and recommendations on how cohort governance and data processing could be designed to meet both regulatory and social challenges, and fulfil their research mission.
We believe that the focus of this research is unique. Our aim is to find out whether there are good governance mechanisms in cohorts, and if these can compensate for lack of granular consent from individual participants for new (sub)studies.

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